SAFLUTAN 15 micrograms/ml eye drops, solution in single-dose container

  • Name:

    SAFLUTAN 15 micrograms/ml eye drops, solution in single-dose container

  • Company:
    info
  • Active Ingredients:

    Tafluprost

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 14/12/20

files-icon(Click to Download)

XPIL

Summary of Product Characteristics last updated on medicines.ie: 14/12/2020

Click on this link to Download PDF directly

Santen UK Limited

Santen UK Limited

Company Products

Medicine NameActive Ingredients
Medicine Name COSOPT 20 mg/ml + 5 mg/ml, eye drops, solution Active Ingredients Dorzolamide Hydrochloride, Timolol Maleate
Medicine Name COSOPT Preservative-Free 20 mg/ml + 5 mg/ml, eye drops, solution in single-dose container Active Ingredients Dorzolamide Hydrochloride, Timolol Maleate
Medicine Name IKERVIS 1 mg/mL eye drops, emulsion Active Ingredients Ciclosporin
Medicine Name Saflutan 15 micrograms/ml eye drops, solution Active Ingredients Tafluprost
Medicine Name SAFLUTAN 15 micrograms/ml eye drops, solution in single-dose container Active Ingredients Tafluprost
Medicine Name Taptiqom 15 micrograms/ml + 5 mg/ml eye drops, solution in single-dose container Active Ingredients Tafluprost, Timolol Maleate
Medicine Name Timoptol 0.25% and 0.5% w/v Eye Drops Solution Active Ingredients Timolol Maleate
Medicine Name TRUSOPT 20 mg/ml eye drops, solution Active Ingredients Dorzolamide Hydrochloride
Medicine Name TRUSOPT Preservative-Free 20 mg/ml eye drops, solution Active Ingredients Dorzolamide Hydrochloride
1 - 0 of 9 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 14 December 2020 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 2

SAFLUTAN contains phosphates

This medicine contains approximately 0.04 mg phosphates in each drop which is equivalent to 1.2 mg/ml. If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.

Section 4

Effects on the respiratory system:

  • worsening of asthma, shortness of breath

In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Ireland: HPRA Pharmacovigilance, Website: www.hpra.ie Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971; Fax: +353 1 6762517, Website: www.hpra.ie; e-mail: medsafety@hpra.ie

Malta: ADR Reporting, Website: www.medicinesauthority.gov.mt/adrportal

The Medicines Authority, Post-Licensing Directorate, 203 Level 3, Rue D'Argens, GŻR-1368 Gżira Website: www.medicinesauthority.gov.mt, e-mail: postlicensing.medicinesauthority@gov.mt

section 6

This leaflet was last revised March 2020 December 2020

Updated on 14 December 2020 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2

One ml of eye drops, solution, contains 15 micrograms of tafluprost.

One single-dose container (0.3 ml) of eye drops, solution, contains 4.5 micrograms of tafluprost.

One drop (about 30 µmicrol) contains about 0.45 micrograms of tafluprost.

Excipient with known effect:  One ml of eye drops solution contains 1.2 mg phosphates and one drop contains approximately 0.04 mg phosphates.

For the full list of excipients, see section 6.1.

Section 4.8

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, website: www.hpra.ie.Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

Section 10.    

November 2017 10 December 2020

Updated on 24 March 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 6 - Contents of the pack and other information

....

Manufacturer

   Santen Oy

Niittyhaankatu 20 FI-33720,

Kelloportinkatu 1, 33100

Tampere

Finland

This leaflet was last revised March 2020

 

 

Updated on 11 December 2017 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.4       Special warnings and precautions for use

There is a potential for hair growth to occur in areas where tafluprost solution comes repeatedly in contact with the skin surface.

 

4.8 Undesirable effects

Eye disorders

Not known (cannot be estimated from the available data): iritis/uveitis, lid sulcus deepened, macular oedema/cystoid macular oedema.

10 DATE OF REVISION OF THE TEXT

July 2015

November 2017

Updated on 11 December 2017 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 7 December 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 7 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 4 January 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 4 January 2016 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided